Respiratory-gated Transcutaneous Auricular Vagus Nerve Stimulation for Improving Apathy in Parkinson's Disease

Официальное название

Respiratory-gated Transcutaneous Auricular Vagus Nerve Stimulation for Improving Apathy in Parkinson's Disease: A Randomized, Double-blind, Sham-controlled Trial

Обзор

The goal of this clinical trial is to learn whether 100HZ respiratory-gated vagus nerve stimulation (RAVANS) can improve the non-motor symptoms in people with Parkinson's disease (PD). It will also learn the safety of 100HZ RAVANS. The main questions it aims to answer are: Can 100HZ RAVANS improve apathy in people with PD? Did the participants have any side effects or safety issues when undergoing 100HZ RAVANS? Researchers compared 100HZ RAVANS with sham stimulation (low-dose stimulation of the same site and treatment parameters) to see if 100HZ RAVANS could improve non-motor symptoms in patients with PD. Participants will: Receive 100HZ RAVANS or sham stimulation for 2 weeks. Neuropsychological assessment, imaging and biological sample collection were conducted before and after the entire cycle.

Подробное описание

This study employs a double-blind, sham-controlled design to further validate the effects of 100Hz RAVANS on apathy . Patients were randomized into real or sham stimulation groups. Both groups will receive RAVANS once daily, with each session lasting 30 minutes, for a total duration of two weeks. The study design will include neuropsychological assessments, imaging, and biological specimen collection before and after the entire cycle.

Вмешательства

• Другое Active RAVANS
  Real RAVANS was performed on the cymba conchae of left ear in the vicinity of the auricular branch vagus nerve according to the Participant's respiratory rhythm. Stimulation parameters: frequency = 100 Hz; pulse width = 200 us, once a day, 30 minutes each time, one second of stimulation occurs during exhalation.
• Другое Sham RAVANS
  Sham RAVANS was performed on on the cymba conchae of left ear according to the Participant's respiratory rhythm. Stimulation parameters: frequency = 100 Hz; pulse width = 200 us, once a day, 30 minutes each time, one second of stimulation occurs during exhalation and the interval between stimulus is 29 seconds.

Первичные конечные точки

• Apathy Motivation Index (AMI) [Срок оценки: baseline; 2 weeks; 6weeks; 8weeks; 10 weeks]

Вторичные конечные точки (12)

• Non-Motor Symptoms Scale, Second Version (NMSS-2) [Срок оценки: baseline; 2 weeks; 6weeks; 8weeks; 10 weeks]
• AMI subscales [Срок оценки: baseline; 2 weeks; 6weeks; 8weeks; 10 weeks]
• Epworth Sleepiness Scale (ESS) [Срок оценки: baseline; 2 weeks; 10 weeks]
• Fatigue Scale-14 (FS-14) [Срок оценки: baseline; 2 weeks; 10 weeks]
• Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: baseline; 2 weeks; 10 weeks]
• REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ) [Срок оценки: baseline; 2 weeks; 10 weeks]
• The Unified Parkinson's Disease Rating Scale, Part III (UPDRS-III) [Срок оценки: baseline; 2 weeks; 10 weeks]
• The Neuropsychiatric Inventory (NPI) [Срок оценки: baseline; 2 weeks; 10 weeks]
• The Hamilton Anxiety Rating Scale (HAMA) [Срок оценки: baseline; 2 weeks; 10 weeks]
• The Hamilton Depression Rating Scale (HAMD) [Срок оценки: baseline; 2 weeks; 10 weeks]
• Heart Rate Variability (HRV) [Срок оценки: baseline everyday; during the intervention everyday]
• Behavioral performance and computational parameters in an effort-based decision-making task [Срок оценки: baseline; 2 weeks]

Критерии участия

Критерии включения

• Meet the diagnostic criteria for idiopathic Parkinson's disease (based on the MDS Clinical Diagnostic Criteria for Parkinson's Disease (2015 version)).
• Patients with Apathy Motivation Index (AMI) score >1.7.
• All PD patients must be on stable, standardized medication regimens with no adjustments to medications for at least 1 month prior to the study and throughout the study period.
• Demonstrate good compliance and adherence, capable of completing behavioral tests and taVNS therapy.
• Mini-Mental State Examination (MMSE) score ≥22.
• Meet safety criteria for MRI screening.

Критерии исключения

• Prior brain MRI/CT showing focal brain lesions or severe white matter disease (Fazekas grade 3 or higher).
• Secondary parkinsonism (e.g., vascular parkinsonism, drug-induced parkinsonism).
• History of severe traumatic brain injury, neurosurgery, or deep brain stimulation (DBS) therapy.
• Personal history of epilepsy, unexplained loss of consciousness, or current use of anticonvulsant medications for seizure control.
• Diagnosis of neuropsychiatric disorders other than Parkinson's disease.
• Current use of non-steroidal anti-inflammatory drugs (NSAIDs) or Non-benzodiazepine GABA receptor agonist drug or anticholinergics or corticosteroids, or history of substance abuse or drug addiction.
• Participation in any clinical trial within the past 3 months.
• Severe systemic comorbidities (e.g., hepatic/renal failure, arrhythmias, organic heart disease).
• Pregnant/lactating women or subjects (including males) planning pregnancy within 6 months.
• Contraindications to taVNS, such as cardiac pacemakers, post-DBS surgery, or auricular pathologies (e.g., tympanic membrane perforation).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Cognitive Neuropsychology Lab Anhui Medical University — Хэфэй

Идентификаторы

NCT: NCT07118956 · PD-TaVNS-RCT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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